LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
FDA 510(k) K213858 · DiaSorin, Inc.
510(k) numberK213858
Submission
- Device name
- LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- December 10, 2021
- Decision date
- July 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NXO – Calprotectin, Fecal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5180
- Specialty
- Immunology
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
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| K191718 | Buhlmann fCAL turbo and CALEX CapNXO · Traditional | Buhlmann Laboratories AG | 09/24/2019SE |
| K191592 | CalprestNG, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K191589 | Calprest, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K190784 | BUHLMANN fCAL turboNXO · Traditional | Buhlmann Laboratories AG | 06/25/2019SE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional | DiaSorin, Inc. | 12/26/2018SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | Inova Diagnostics, Inc. | 10/16/2018SE |
| K181012 | BUHLMANN fCAL ELISANXO · Traditional | Buhlmann Laboratories AG | 06/04/2018SE |
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Questions and answers
When was LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus cleared by the FDA?
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) received a 510(k) decision of Substantially Equivalent on July 26, 2022, 228 days after the submission was received.
What is the product code of K213858?
The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.